NCT00459927

Brief Summary

The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
2.2 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

First QC Date

April 11, 2007

Last Update Submit

March 18, 2014

Conditions

Adenotonsillar HypertrophyTonsillitisObstructive Sleep Apnea

Keywords

AdenotonsillectomyCoblation tonsillectomyFloseal

Outcome Measures

Primary Outcomes (2)

  • Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss

    intraoperative period

  • Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity

    postoperative period

Interventions

Floseal tonsillectomyDEVICE
Coblation tonsillectomyDEVICE

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients less than 18 years old scheduled for a routine adenotonsillectomy

You may not qualify if:

  • Down syndrome
  • Craniofacial abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TonsillitisSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Joshua A Gottschall, M.D.

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

July 1, 2009

Last Updated

March 19, 2014

Record last verified: 2014-03